Clinical Protocol and Data Management ? Project Summary The Clinical Protocol and Data Management (CPDM) function at the University of Kansas Cancer Center (KUCC) resides within the Clinical Trials Office (CTO). The CTO, led by Stephen Williamson, MD (Medical Director of the CTO and Early Phase Clinical Research Program) and Hobs Apell, (Senior Executive Director) provides comprehensive support services that span the life cycle of cancer clinical trials from concept through manuscript. The CTO provides a central location for protocol management and reporting. There is a strong emphasis on assuring data integrity and compliance as well as emphasis on the education and training of CTO staff and investigators. There is also a strong emphasis on achieving timelines for rapid submission and activation of protocols while observing all regulatory requirements. To further translational research and mentorship goals, the Investigator-Initiated Trial Steering Committee (IITSC) was established in 2015. The IITSC, chaired by Williamson, and Scott Weir, PharmD, PhD (Associate Director for Translational Research), was formed to mentor and educate junior investigators and to support the acceleration of scientific discovery of novel therapeutics through the conduct of investigator-initiated clinical trials. Over the last four years, substantial progress has been made broadening clinical research partnerships with communities throughout our catchment area. Three major changes have expanded the composition of clinicians participating in the clinical trials process. The first change results from the incorporation of a large private practice oncology group by the University of Kansas Health System, a group now defined as the KUCC community oncology program. The second change is the expansion of the outreach network of KUCC, known as the Midwest Cancer Alliance (MCA), which is a membership fee-based network of hospitals and physician groups located across the KUCC catchment area. Many MCA centers serve as affiliate sites to cooperative group sponsored trials and investigator-initiated trials conducted by KUCC as the Primary Center. The third change results from the 2015 consortium agreement with Children's Mercy incorporating their clinicians into KUCC programs. The CTO has enabled a steady increase in clinical trials accrual at KUCC since receiving NCI Designation. Accrual to Intervention clinical trial protocols increased overall by 21% (2,097 accruals in 2012 to 2,544 accruals in 2015). Accrual to Interventional investigator-initiated trials (IIT) increased by 12% (1,140 accruals in 2012 to 1,275 accruals in 2015). Notably, in 2015, institutionally sponsored IITs accounted for nearly 50% of all KUCC intervention clinical trial enrollments. Accrual to Industrial Sponsored Interventional Trials increased more than 160% (96 accruals in 2012 to 256 accruals in 2015). In summary, the CTO has facilitated significant growth of clinical research, while implementing cost-effective processes to ensure that the research activities have scientific merit, protect safety, and maintain scientific integrity.